P East Trading Corporation – FDA Warning Letter, Jul 9, 2008

On July 1 & 9, 2008, the FDA inspected East Trading Corporation, a seafood processor and importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's refrigerated salted mackerel fillets and smoked herring fillets adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for refrigerated salted mackerel and smoked herring fillets failed to list pathogen growth and toxin formation, including *Clostridium botulinum*, as a food safety hazard at the "receiving" and "storage" critical control points (CCPs), violating 21 CFR 123.6(a) and (c)(1). 2. **Insufficient Monitoring Procedures:** The HACCP plan's monitoring procedures for "receiving" and "storage" CCPs for scombrotoxin formation were inadequate. They only referenced taking product temperatures upon receipt and (b)(4) for storage, lacking continuous temperature monitoring recommended by the FDA, violating 21 CFR 123.6(c)(4). 3. **Failure to Implement Importer Verification:** The firm failed to implement its written affirmative step procedures for imported fish and fishery products from (b)(4) suppliers. Specifically, it